Company ยท US
Coeur Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1997. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 8, 1997 | K971712 | COEUR 130 ML ANGIOGRAPHIC SYRINGE Coeur Laboratories, Inc. | DXT |
| Mar 28, 1997 | K965214 | COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) Coeur Laboratories, Inc. | DTX |
| Sep 12, 1996 | K960965 | FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 Coeur Laboratories, Inc. | DXT |
| Jun 22, 1989 | K890292 | PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE Coeur Laboratories, Inc. | DXT |
| Feb 7, 1989 | K885138 | CAPILLARY TUBE, BLOOD COLLECTION Coeur Laboratories, Inc. | GIO |
| Jan 31, 1989 | K885202 | 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR Coeur Laboratories, Inc. | KOD |
| Jun 16, 1988 | K881646 | UROLOGICAL CATHETER Coeur Laboratories, Inc. | KOD |
| Jan 19, 1988 | K874579 | COEUR CONTROL SYRINGE Coeur Laboratories, Inc. | FMF |
| Nov 12, 1987 | K873597 | TUBING, POLYETHYLENE Coeur Laboratories, Inc. | DXT |
| Feb 18, 1983 | K823920 | COEURLOCK STERILE DISPOS. ANGIOGRAPHIC Coeur Laboratories, Inc. | DXT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||